WL-AAB-Z-W-1173 by Nanophase Technologies Corporation / Amcol Health & Beauty Solutions WL-AAB-Z-W-1173

WL-AAB-Z-W-1173 by

Drug Labeling and Warnings

WL-AAB-Z-W-1173 by is a Otc medication manufactured, distributed, or labeled by Nanophase Technologies Corporation, Amcol Health & Beauty Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WL-AAB-Z-W-1173- zinc oxide lotion 
Nanophase Technologies Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

WL-AAB-Z-W-1173

WL-AAB-Z-W-1173

GHS Label

WL-AAB-Z-W-1173 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63931-4480
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE132 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
PROPANEDIOL (UNII: 5965N8W85T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63931-4480-1150000 mL in 1 DRUM; Type 0: Not a Combination Product08/26/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/26/2021
Labeler - Nanophase Technologies Corporation (623502044)
Registrant - Nanophase Technologies Corporation (623502044)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation050383046api manufacture(63931-4480)
Establishment
NameAddressID/FEIBusiness Operations
Nanophase Technologies Corporation623502044api manufacture(63931-4480) , manufacture(63931-4480) , pack(63931-4480)
Establishment
NameAddressID/FEIBusiness Operations
Amcol Health & Beauty Solutions872684803api manufacture(63931-4480)

Revised: 9/2021